This is a multicenter, single arm, open label phase II study in treatment-naïve for advanced stage of the disease and immunotherapy-naïve patients with advanced non-squamous NSCLC and with \< 50% of tumor cells expressing programmed death-ligand 1 (PD-L1) by immunohistochemical (IHC) staining.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks
Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance
360 mg IV administration every 3 weeks
Charlotte
Charlotte, North Carolina, United States
Nashville
Nashville, Tennessee, United States
Libramont
Libramont, Belgium
Créteil
Créteil, France
Objective Response Rate (ORR)
Percentage of participants whose best overall response is complete response or partial response using RECIST 1.1. confirmed by a second scan no less than 4 weeks after the criteria for response are first met. Complete response: disappearance of all lesions and no new lesions. Partial response: decrease of at least 30% in the sum of the diameters of measurable lesions taking as reference the baseline sum of diameters, no progression of non-measurable lesions and no new lesions.
Time frame: 15 months
Progression Free Survival (PFS)
Time from the date of the first study drug administration to the date of first documented tumor progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The Kaplan-Meier estimator was used to estimate median PFS and its confidence interval.
Time frame: 28 months
Disease Control Rate (DCR)
Percentage of participants whose best overall response is either complete response, partial response or stable disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions and no measurable non-target lesions; Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD).
Time frame: 15 months
Overall Survival
Overall Survival (OS) is defined as the time from the first study drug administration to the date of death due to any cause. The Kaplan-Meier estimator was used to estimate median OS and its confidence interval.
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Mulhouse
Mulhouse, France
Rennes
Rennes, France
Strasbourg
Strasbourg, France
Budapest
Budapest, Hungary
Szekesfehervar
Székesfehérvár, Hungary
Time frame: 28 months
Duration of Overall Response (DoR)
Time from first documented response (complete response or partial response) until documented disease progression or death due to lung cancer.
Time frame: 28 months
Number of Participants With Adverse Events or Abnormalities
The assessment of safety of the combination was based mainly on the frequency of adverse events, serious adverse events, adverse events of special interest (Injection site reaction, fatigue, pyrexia, infusion-related reactions and diarrhea), immune-mediated adverse events and laboratories abnormalities.
Time frame: 28 months